Presume that the study to be conducted

Assignment Help Science

Reference no: EM133568874

Question: Using the FDA guidance "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry", use the template for a Pre-IND Meeting and prepare a Pre-IND Meeting Request and Package--NOTE: These are two separate documents with clear distinction in the guidance! You may include both documents in one file or upload each document separately as individual files when submitting your assignment. Also take the drug Guselkumab (Tremfya) and explain the all details with APA Citation.

Presume that the study to be conducted within the United States is a Phase 3 study with Phases 1 and 2 being conducted ex-US.

Reference no: EM133568874

Questions Cloud

Can codes for debridement of wounds : Can codes for debridement of wounds (11042 - 11047) be reported with the codes from this section if both procedures are performed on the same wound

Discuss what challenges this weeks discussion : checklist and NIH Phase 2 and 3 IND/IDE Protocol Word Template. Discuss what challenges this week's discussion board exercise presented

What were primary differences between monitorial schools : What were primary differences between monitorial schools, Sunday Schools, and free school societies established during the American Revolution?

Explain using relational inquiry, lenses including the 5c''s : Using the 5W's describe an outstanding situation in your clinical experience and explain using relational inquiry, lenses including the 5C's

Presume that the study to be conducted : Presume that the study to be conducted within the United States is a Phase 3 study with Phases 1 and 2 being conducted ex-US

Explain how the revolution symbolized a quest for liberty : Explain how the Revolution symbolized a quest for liberty, self-determination, and freedom from British oppression. Reference the Declaration of Independence

What things did you anticipate for your patient this week : What things did you anticipate for your patient this week? (CO #2) After getting report each morning, what expectations did you have for your patient

Discuss the health promotion associated with the group : This group project where your group will be teaching the rest of the class on an assigned aged group and the health promotion associated with the group.

What lesson we can learn from women history : What lesson we can learn from women's history? What strategies were used and what lessons can well learn from the struggles women faced in the late 1800s-

User Account

All Pages